NCT02434107已完成不适用
Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 41
- 主要终点
- Distant metastases free survival
研究概览
简要总结
Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cutaneous melanoma with a tumour thickness of at least 1,00mm
- •Positive sentinel node with micro metastases of max. 2mm in diameter
排除标准
- •Mucosal or ocular melanoma
- •Cutaneous melanoma located in the head/neck region
- •Evidence of satellite, in transit or local metastases / recurrences
- •Macro metastases of the SN or micro metastases of >2mm in diameter
- •Additional immune-suppressive therapy
- •Pregnant of lactating women
研究组 & 干预措施
Completion Lymphadenectomy
Experimental
Completion Lymphadenectomy and monitoring afterwards
干预措施: Completion Lymphadenectomy (Procedure)
Clinical Monitoring (Palpation and node ultrasound)
Experimental
Monitoring only
干预措施: Clinical Monitoring (Palpation and node ultrasound) (Procedure)
结局指标
主要结局
Distant metastases free survival
时间窗: 3 Years
次要结局
- Distant metastases free survival(5 Years)
研究者
研究点 (41)
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